PDF(Pubmed)
Abstract：
The mpox 2022 outbreak was declared a public health emergency in July 2022. In August 2022, the MVA-BN vaccine received emergency use authorization in the United States (US) to target at-risk groups. This study (EUPAS104386) used HealthVerity\'s administrative US healthcare data to generate real-world evidence for MVA-BN vaccine effectiveness and safety to prevent mpox disease in men who have sex with men (MSM) and transgender women, the most affected population during the 2022 mpox outbreak. Fully vaccinated subjects (two doses ≥ 28 days apart) were initially matched with five unvaccinated subjects on calendar date, age, US region, and insurance type. Subjects were followed from index date (14 days after the second dose) until death or data end to ascertain mpox occurrence. After propensity score adjustment, the MVA-BN vaccine effectiveness against mpox disease was 89% (95% CI: 12%, 99%) among those fully vaccinated; attenuated to 64% (95% CI: 40%, 78%) among those with any dose and 70% (95% CI: 44%, 84%) for those with only a single dose. One pericarditis adverse event of special interest was observed when the risk window was extended to 28 days. These results contribute to the totality of evidence supporting the favorable benefit/risk profile of the MVA-BN vaccine.
摘要：
2022年爆发的水痘在2022年7月被宣布为公共卫生紧急事件。2022年8月，MVA-BN疫苗在美国（US）获得了针对高危人群的紧急使用授权。这项研究（EUPAS104386）使用了HealthVerity的美国行政医疗保健数据，为MVA-BN疫苗的有效性和安全性提供了现实证据，以预防男男性行为者（MSM）和变性女性的水痘疾病。2022年水痘疫情期间受影响最严重的人群。完全接种疫苗的受试者（两剂间隔≥28天）最初与日历日期的五名未接种疫苗的受试者相匹配。年龄,美国地区,和保险类型。从索引日期(第二剂量后14天)随访受试者直到死亡或数据结束,以确定痘发生。在倾向得分调整后，MVA-BN疫苗对水痘疾病的有效性为89%(95%CI：12%，99％）在完全接种疫苗的人中；减毒至64％（95％CI：40％，78%)在任何剂量和70%(95%CI：44%，84%），对于那些只有单剂量的人。当风险窗口延长至28天时，观察到一个特别感兴趣的心包炎不良事件。这些结果有助于全部证据支持MVA-BN疫苗的有利益处/风险概况。
